BEUDAMED
    21 results · 20ms · Sources: EU EUDAMED, US FDA

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    ALCO-BREATH TUBE, CHECKPOINT BREATH ALCOHOL TEST

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology

    Dornier MedTech

    FDA UDI
    Dornier MedTech GmbH·04049957000561·UIMS Viewing Station SC Low Line

    SAV

    FDA UDI
    Diversified Products, Inc.·00842894119594·

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776294915·Freeman-Gorney Supercut Scissors straight

    Novo Surgical Inc.

    FDA UDI
    NOVO SURGICAL, INC.·00842331145469·probe w/ eye, usa pattern, stainless steel, 5 1...

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587L102225120·10mm H x 22mm W x 25mm L XLIF Trial 12 degree L...

    OR TABLE/MAGNETOM OPEN VIVA SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    ATTAIN 6215 VENOGRAM BALLOON CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BD SYRINGE 2ML LS EMERALD

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·July 21, 2021

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 30, 2025

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 9, 2013

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code JJE·September 19, 2014

    HUT EXT DR FINAL ASSY-REVERSE

    FDA Adverse Event
    Malfunction ·LIEBEL-FLARSHEIM CO.·Product code KQS·May 17, 2011

    CP5 FLOW MODULE

    FDA Adverse Event
    Malfunction ·LIVANOVA DEUTSCHLAND·Product code DWA·July 18, 2024

    Model Number L231, PROPONENT DR EL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    VALITUDE CRT-P pacemaker, Models: a) U125 b) U128

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·July 14, 2021

    VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    ACCOLADE DR SL (Model L301)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025